Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 April 2019 |
Main ID: |
EUCTR2012-005495-34-DK |
Date of registration:
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06/10/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
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Scientific title:
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A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN |
Date of first enrolment:
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19/11/2015 |
Target sample size:
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1800 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005495-34 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Canada
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Denmark
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France
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Hungary
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Japan
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Korea, Republic of
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Spain
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Sweden
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United States
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Contacts
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Name:
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ClinicalTrials.gov call Center
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Address:
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235 East 42nd Street
NY 10017
New York
United States |
Telephone:
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+1800718 1021 |
Email:
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clinicaltrials.govcallcenter@pfizer.com |
Affiliation:
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Pfizer Inc |
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Name:
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ClinicalTrials.gov call Center
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Address:
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235 East 42nd Street
NY 10017
New York
United States |
Telephone:
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+1800718 1021 |
Email:
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clinicaltrials.govcallcenter@pfizer.com |
Affiliation:
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Pfizer Inc |
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Key inclusion & exclusion criteria
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Inclusion criteria: -Chronic low back pain =3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.
Refer to protocol for full list of inclusion criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1530 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 270
Exclusion criteria: -Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria.
Subjects who have Kellgren Lawrence Grade =2 radiographic evidence of hip or Grade =3 radiographic evidence of knee osteoarthritis will be excluded;
-History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., rheumatoid arthritis).
-History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
-Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study
-History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol
-Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
Please refer to the protocol for the remaining exclusion criteria
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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CHRONIC LOW BACK PAIN
MedDRA version: 19.0
Level: LLT
Classification code 10024891
Term: Low back pain
System Organ Class: 100000004859
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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Product Name: Tanezumab Product Code: PF-04383119 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Tanezumab CAS Number: 880266-57-9 Current Sponsor code: PF-04383119 Other descriptive name: RI624, RN624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Product Name: Tanezumab Product Code: PF-04383119 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Tanezumab CAS Number: 880266-57-9 Current Sponsor code: PF-04383119 Other descriptive name: RI624, RN624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Product Name: Tramadol Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Tramadol CAS Number: 27203-92-5 Other descriptive name: TRAMADOL HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Modified-release tablet Route of administration of the placebo: Oral use
Product Name: Tramadol Pharmaceutical Form: Modified-release tablet INN or
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Primary Outcome(s)
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Main Objective: Demonstrate superior analgesic efficacy of tanezumab 10 mg and 5 mg administered subcutaneously (SC) every 8 weeks compared to placebo at Week 16.
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Secondary Objective: -Evaluate the long-term safety of tanezumab 10 mg and 5 mg SC administered every 8 weeks (7 administrations); -Estimate the long-term analgesic efficacy of tanezumab 10 mg and 5 mg SC administered every 8 weeks (7 administrations) up to Week 56; - Compare the analgesic efficacy of tanezumab 10 mg SC administered every 8 weeks relative to an active comparator (oral tramadol PR) at Week 16.
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Primary end point(s): Change from Baseline to Week 16 in the daily average Low Back Pain Intensity (LBPI) score as measured by an 11-point Numeric Rating Scale for tanezumab vs placebo.
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Timepoint(s) of evaluation of this end point: Please refer to the protocol
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Secondary Outcome(s)
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Secondary end point(s): -Key Secondary Endpoints:
-Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire(RMDQ) for tanezumab vs placebo;
-Change from Baseline to Week 16 in the daily average LBPI score as measured by an 11-point Numeric Rating Scale for tanezumab vs. tramadol PR.
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Timepoint(s) of evaluation of this end point: Please refer to the protocol
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Secondary ID(s)
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A4091059
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2012-005495-34-SE
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Source(s) of Monetary Support
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Pfizer Inc, 235 East 42nd Street, New York, NY 10017
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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